The CareFUL Prevention Trial (CareFULPrevent)

This study has been completed.

Sponsor:

DIApedia, LLC

ClinicalTrials.gov Identifier:

NCT00803608

First Posted: December 5, 2008

Last Update Posted: August 13, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Collaborator:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

To assess the efficacy of TrueContour® Insoles versus the current standard of care insoles in recurrence of plantar MTH ulcers in men and women, 18 years of age or older at the time of consent with clinical diagnosis of Diabetes Mellitus type 1 or type 2 who have had at least one recently healed plantar MTH foot ulcer (>1 week but <12 weeks since heeling) and have Loss of Protective Sensation.

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Men and women, 18 years of age or older at the time of consent;

Clinical diagnosis of Diabetes Mellitus ;

At least one recently healed plantar MTH-related foot ulcer (>1 week but 4 months since heeling), based on medical records or if these cannot be obtained to the subject's best recollection OR current or recurring hemorrhage into callus under at least one MTH in a patient with a prior MTH related plantar ulcer that has been documented in the medical record;

Barefoot plantar pressure in the area of the previous MTH-related ulcer or at the area of current hemorrhagic callus >450 kPa;

Loss of Protective Sensation (refer to Section 7.2.6);

Community ambulator defined as having the ability or potential for ambulation outside in the community including the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces, or better by subject report;

Ability to give consent;

In the opinion of the site PI the subject is willing and able to comply with the scheduled visits, treatment plan, and other trial procedures for the duration of the study.

Exclusion Criteria:

Presence of a current ulcer (see Section 7.1.1) below the malleoli, in the opinion of the site PI;

Partial foot amputation greater than of two metatarsal heads or rays per foot; toe amputations with the metatarsal heads left in place are permissible; complete foot amputation on one side (i.e. ambulation with a prosthesis) is permissible;

Charcot process that is active in the opinion of the site PI (requires immobilization beyond use of footwear that would be available through the study);

A prior ulcer on the plantar aspect of the heel within the last year, to the subject's best recollection that in the opinion of the site PI has high probability of recurring in the study footwear;

A prior ulcer on the weightbearing aspect of any toe within the last year, to the subject's best recollection that in the opinion of the site PI has high probability of recurring in the study footwear;

A prior ulcer on the plantar aspect of the foot associated with a mid-foot prominence at any time in the past, to the subject's best recollection that in the opinion of the site PI has high probability of recurring in the study footwear;

A prior ulcer on the plantar aspect of the foot associated with a mid-foot prominence at any time in the past, if the associated plantar pressure is >450kPa

Need for an ankle-foot orthoses in the opinion of the site PI or another provider;

Need for more complex intervention, i.e. the site PI's decision is that the study footwear would not be adequate for the subject's needs, e.g. a rigid outsole or custom molded shoes are deemed necessary.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803608

Locations

United States, Arizona

Carl T Hayden VA Medical Center

Phoenix, Arizona, United States, 85012

Southern Arizona Limb Salvage Alliance

Tucson, Arizona, United States, 85711

United States, California

Center for Clinical Research, Inc

Castro Valley, California, United States, 94546

Innovative Medical Technologies

Los Angeles, California, United States, 90024

United States, Colorado

Diabetic Foot and Wound Center

Denver, Colorado, United States, 80220

United States, Illinois

Weil Foot & Ankle Institute

Des Plaines, Illinois, United States, 60016

Hines VA Hospital

Hines, Illinois, United States, 60141

United States, Ohio

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44193

United States, Pennsylvania

Blair Medical Associates, Inc

Altoona, Pennsylvania, United States, 16602

Temple University School of Podiatric Medicine

Philadelphia, Pennsylvania, United States, 19107

United States, Texas

Complete Family Footcare

McAllen, Texas, United States, 78501

Sponsors and Collaborators

DIApedia, LLC

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)